Biological lumens can be severed through a variety of causes including, for example, accidental injury or intentional surgical procedures. For example, individuals can choose to be permanently sterilized through the surgical severing of the fallopian tubes in females or the severing of the vas deferens in males. However, in some instances, individuals can subsequently desire to reverse the sterilization procedure by restoring the severed biological lumen. In other cases, biological lumens severed by injury or disease can also require restoration. The severed biological lumen can be restored by rejoining the severed biological lumen through an anastomosis procedure.
Anastomosis procedures typically involve the realignment and reconnection of the opposed stumps of the severed biological lumen and retaining the stumps together until the biological lumen is restored. However, the traditional suturing based procedure is hampered by the difficulty of effectively suturing the relatively small biological lumen or the close proximity of the surgical site to sensitive tissues, which increases the risk of the procedure being performed incorrectly and complications arising from the anastomosis procedure. Complications specific to the surgical site could include leakage of the biological lumen, difficulty in healing or outright failure of the wound to heal. General complications such as incontinence or impotence can also result if the procedure is not properly performed.
Various anastomosis devices have been developed that use alternative means of rejoining the severed biological lumens and retaining the stumps until the biological lumen is restored instead of the traditional sutures. Commercially, a representative anastomosis device includes those available from American Medical Systems of Minnetonka, Minn. and which are further described in U.S. Patent Publication Nos. 2004/0087995, 2005/0070938, 2005/0131431, 2006/0200178, 2006/0264985, 2006/0276811 and 2007/0219584, all of which are hereby incorporated by reference in their entireties. An anastomosis device can generally comprise an elongated body have a pair of deployable approximation structures disposed at a distal working end of a device body. Typically, the anastomosis device comprises a catheter style body which is inserted through the severed lumen until at least the distal working end of the anastomosis device protrudes from a proximalmost stump. A manipulation assembly at a proximal end of the catheter allows a medical professional to control the positioning of the anastomosis device and the deployment/retraction of the approximation structures at the distal working end. The distal working end of the anastomosis device is then advanced into a lumen opening on a distal stump such that the distal stump can be grasped and retained by deploying a distalmost set of approximation structures. A pulling force is then applied to the manipulation assembly of the anastomosis device to draw the distal and proximal stumps into operational contact to restore the biological lumen. In a typical anastomosis procedure, the pulling force applied by the medial professional is ideally be between 1 and 2 pounds of force to insure the distal and proximal stumps are properly joined without damaging the tissue of the biological lumen.
The pulling force is typically applied by medical personnel to the manipulation assembly which translates the pulling force to anastomosis device via the catheter body as well as wires disposed within the catheter body that operably connect the manipulation assembly with the distal treatment end. As the ideal range of the pulling force is relatively small, it can be difficult for inexperienced medical personal to successfully apply the pulling forces. As such, it would be advantageous to allow medical professionals to simulate the application of pulling force prior to conducting an actual anastomosis procedure.